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Completed

NCT Number: NCT01655953

Changes in Acid Base Status During High Salt Intake

The study aimed to examine the effects of an alkalinisation of a NaCl (sodium chloride, salt)-rich diet on acid base status, bone metabolism, protein turnover and other influenced physiological systems. Due to increased urinary calcium excretion and bone resorption a high NaCl-intake is considered as a risk factor for osteoporosis. On the contrary an alkaline diet is known to have a beneficial influence on bone metabolism. Therefore the investigators hypothesized that an alkaline diet can reduce NaCl-induced bone resorption.

8 healthy male volunteers took part in a stationary study carried out in the metabolic ward of the German Aerospace Center. The study consisted of 2 campaigns, each lasting 16 days. Both campaigns were divided into 5 days of adaptation, 10 days of intervention and 1.5 days of stationary recovery. During the intervention period the volunteers diet was NaCl-rich (7.7 mmol Na/kg body weight/day) and supplemented in one campaign by 90 mmol potassium bicarbonate (KHCO3) in a randomized cross-over design. The other campaign served as control.

Bone metabolism was studied by bone formation markers in the fasting morning blood and 24h-urinary bone resorption markers. Acid base status was assessed by blood gas analyses in the fasted and the postprandial state as well as urinary markers. Protein turnover was studied with stable isotopes. Further physiological systems like energy metabolism and the cardiovascular system are also under investigation.

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Key information

Age range

19 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

German Aerospace Center (DLR)

Cologne, 51147, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy males
  • 19 - 35 years
  • 65 - 85kg
  • 170 - 190 cm
  • successfully completed psychological and medical screening

Exclusion criteria

  • athletes
  • smoking
  • drug- or alcohol abuse
  • hyperlipidemia
  • renal diseases
  • obesity
  • anemia
  • bone diseases
  • diabetes
  • rheumatism
  • blood donation within three month prior to study start
  • participation in another clinical investigation three month prior to study start

Treatment and study plan

High NaCl + KHCO3

Dietary Supplement

7.7 mmol Na/kgBW/d + 90 mmol KHCO3

Control: high NaCl

Other

7.7 mmol Na/kgBW/d

Primary outcomes

  1. Change in daily urinary C- and N-terminal bone collagen telopeptides (mmol/d)

    Time frame: Daily for a duration of 16 days

Secondary outcomes

  1. Serum concentration of bone specific alkaline phosphatase (microg/L)

    Time frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing the intervention

  2. Daily Nitrogen balance (g/d)

    Time frame: Daily for a duration of 16 days

  3. Free cortisol excretion in 24h urine (microg/d)

    Time frame: Baseline, after 3, 6, 10 days of intervention

  4. Phenylalanine hydroxylation (micromol/min)

    Time frame: Baseline, end of intervention

  5. Systolic blood pressure (bpm)

    Time frame: Daily for a duration of 16 days

  6. 24h urinary net acid excretion (mEq/d)

    Time frame: Baseline, end of intervention

  7. Serum concentration of N-terminal propeptide Type I (mmol/L)

    Time frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention

  8. Free cortisone excretion in 24h urine (microg/d)

    Time frame: Baseline, after 3, 6, 10 days of intervention

  9. Protein synthesis (micromol/min)

    Time frame: Baseline, end of intervention

  10. Protein degradation (micromol/min)

    Time frame: Baseline, end of intervention

  11. Diastolic blood pressure (bpm)

    Time frame: Daily for a duration of 16 days

  12. Capillary pH

    Time frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention

  13. Capillary HCO3- Concentration (mmol/L)

    Time frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention

  14. Capillary Base excess (mmol/L)

    Time frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention

  15. Capillary pCO2 (mmHg)

    Time frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention

  16. Capillary pO2 (mmHg)

    Time frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention

Sponsors and collaborators

Lead sponsor

DLR German Aerospace Center

Other

Collaborators

  • Charite University, Berlin, Germany
  • University of Erlangen-Nürnberg

Registry information

Acronym: SL8

Important dates

Study start
2007
Study completion
2007
First posted
Aug 2, 2012
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.